Acute Respiratory Viral InfectionPhase 3NCT06715891
Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years
A Phase 3 study testing Raphamin in people with Acute Respiratory Viral Infection, run by Materia Medica Holding at 35 sites in Russia.
Trial summary
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Acute Respiratory Viral Infection
- What is being tested?
- Raphamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- 35 sitesRussia
- Study dates
- 11 Nov 2024to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either gender aged 3 to12 years .
- Diagnosis of ARVI based on the medical examination: axillary temperature ≥37.8°C at the time of examination + total severity of general symptom score ≥4 points, nasal/throat/chest symptoms ≥2 points (ARVI Symptom Severity Score).
- 24 hours from the ARVI onset .
- Availability of a patient information sheet and an informed consent form for the patient's parents/adopters for patient participation in the clinical trial signed by one parent/adopter of the patient.
Who cannot join
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring the administration of antibiotics from the first day of disease.
- Suspected early manifestations of diseases that have onset symptoms similar to those of ARVI (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue diseases and other pathologies).
- Patients who require administration of antiviral medications that are prohibited for use in this trial.
- History or prior diagnosis of primary and secondary immunodeficiency.
- History/suspicion of oncology of any localization (except for benign neoplasms).
Show all 15Show fewer
- Exacerbation or decompensation of chronic diseases (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Allergy/hypersensitivity to any component of the medicines used in the treatment.
- Use of medications listed under "Prohibited Concomitant Treatment" within 2 weeks prior to inclusion in the trial.
- Patients whose parents/adopters, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.
- History of mental illness of the patient (except for attention deficit hyperactivity disorder), parents/adopters of the patient.
- Participation in other clinical trials within 3 months prior to inclusion in this trial.
- A patient's parent/adopter is related to any of the on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.
- The patient's parent/adopter is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
35 sites in 1 country
Russia35 sites, 34 recruiting
- Recruiting
Gatchina Clinical Interdistrict Hospital
Gatchina, 188300
Asmik Asatryan, MD
Asmik Asatryan, MD
- Recruiting
Kazan State Medical University/Department of Hospital Pediatrics
Kazan', 420012
Hakim Vakhitov, MD, PhD
Hakim Vakhitov, MD, PhD
- Recruiting
LLC "MedLight"
Kazan', 420097
Alsu Nurmeeva, MD, PhD
Alsu Nurmeeva, MD, PhD
- Recruiting
Regional Clinical Hospital # 2
Krasnodar, 350012
Konstantin Lobanov, MD
Konstantin Lobanov, Konstantin
- Recruiting
Specialized Clinical Infectious Diseases Hospital
Krasnodar, 350015
Larisa Dubova, MD, PhD
Larisa Dubova, MD, PhD
- Recruiting
Central Research Institute of Epidemiology/Clinical Department of Infectious Pathology
Moscow, 111123
Antonina Ploskireva, MD, PhD
Antonina Ploskireva, MD, PhD
- Recruiting
Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department
Moscow, 119049
Alexey Rtishchev, MD, PhD
Alexey Rtishchev, MD, PhD
- Recruiting
First Moscow State Medical University named after I.M. Sechenov/Department of Childhood Diseases
Moscow, 119991
Natalia Geppe, Prof.
Natalia Geppe, Prof.
- Terminated
Llc "Diagnostics and Vaccines"
Moscow, 129515
- Not yet recruiting
LLC "Health Laboratory"
Mytishchi, 141002
Evgeniya Uleva, MD
Evgeniya Uleva, MD
- Recruiting
Novosibirsk State Medical University/Clinic "Medical Advisory Center"
Novosibirsk, 630091
Elena Kondyurina, Prof.
Elena Kondyurina, Prof.
- Recruiting
Omsk State Medical University/Department of Hospital Pediatrics with a Course of Continuing Professional Education
Omsk, 644099
Elena Pavlinova, Prof.
Elena Pavlinova, Prof.
- Recruiting
City Children's Clinical Polyclinic # 5
Perm, 614066
Olga Perminova, MD, PhD
Olga Perminova, MD, PhD
- Recruiting
LLC "Professor's Clinic"
Perm, 614070
Svetlana Teplykh, MD, PhD
Svetlana Teplykh, MD, PhD
- Recruiting
LLC "4D Ultrasound Clinic"
Pyatigorsk, 357502
Galina Dulova, MD
Galina Dulova, MD
- Recruiting
Clinical and diagnostic center "Health"
Rostov-on-Don, 344011
Alexey Sarychev, MD, PhD
Alexey Sarychev, MD, PhD
- Not yet recruiting
LLC "Eurodon Clinic"
Rostov-on-Don, 344022
Anna Savisko, MD, PhD
Anna Savisko, MD, PhD
- Not yet recruiting
Rostov State Medical University/Department of Childhood Diseases # 2
Rostov-on-Don, 344022
Stanislav Maltsev, MD, PhD
Stanislav Maltsev, MD, PhD
- Not yet recruiting
Rostov State Medical University/Department of Childhood Diseases # 3
Rostov-on-Don, 344022
Marina Lukashevich, MD, PhD
Marina Lukashevich, MD, PhD
- Recruiting
Ryazan State Medical University named after Academician I.P. Pavlov/Department of Children's Diseases with a course in hospital pediatrics
Ryazan, 390026
Andrey Dmitriev, MD, PhD
Andrey Dmitriev, MD, PhD
- Recruiting
Children's City Polyclinic # 44
Saint Petersburg, 191144
Andrey Kamaev, Md, PhD
Andrey Kamaev, Md, PhD
- Recruiting
Saint Petersburg State Pediatric Medical University/Department of Infectious Diseases of Adults and Epidemiology
Saint Petersburg, 194100
Elena Esaulenko, Prof.
Elena Esaulenko, Prof.
- Recruiting
Children's City Polyclinic # 35
Saint Petersburg, 196191
Tatiana Antonova, MD, PhD
Tatiana Antonova, MD, PhD
- Not yet recruiting
City Polyclinic # 3
Saint Petersburg, 199155
Gleb Kondratiev, MD
Gleb Kondratiev, MD
- Not yet recruiting
City Polyclinic # 4
Saint Petersburg, 199178
Natalia Soroka, MD, PhD
Natalia Soroka, MD, PhD
- Recruiting
Samara Regional Children's Clinical Hospital named after N.N. Ivanovoy/Department of Medical Rehabilitation
Samara, 443079
Tatiana Romanova, MD, PhD
Tatiana Romanova, MD, PhD
- Recruiting
Samara State Medical University/Department of Hospital Pediatrics
Samara, 443099
Liliya Mazur, Prof.
Liliya Mazur, Prof.
- Recruiting
National Research Mordovian State University named after N.P. Ogarev/Department of Pediatrics/
Saransk, 430005
Larisa Balykova, Prof.
Larisa Balykova, Prof.
- Recruiting
Saratov City Children's Clinical Hospital
Saratov, 410064
Elena Mikhailova, Prof.
Elena Mikhailova, Prof.
- Recruiting
Smolensk State Medical University/Department of Children's Diseases of the Medical and Dental Faculties
Smolensk, 214019
Vladimir Bekezin, Prof.
Vladimir Bekezin, Prof.
- Recruiting
Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics
Ufa, 450008
Lyudmila Yakovleva, Prof.
Lyudmila Yakovleva, Prof.
- Recruiting
Yaroslavl State Medical University/Department of Pediatrics, Institute of Continuous Professional Education
Yaroslavl, 150000
Elena Shubina, MD, PhD
Elena Shubina, MD, PhD
- Recruiting
Clinical Hospital # 2
Yaroslavl, 150030
Irina Melnikova, Prof.
Irina Melnikova, Prof.
- Recruiting
Children's City Clinical Hospital # 11 Ekaterinburg
Yekaterinburg, 620028
Sofia Tsarkova, Prof.
Sofia Tsarkova, Prof.
- Recruiting
Ural State Medical University/Department of Infectious Diseases, Phthisiology and Pulmonology
Yekaterinburg, 620028
Alebay Sabitov, Prof.
Alebay Sabitov, Prof.
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 3-12 Years
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
Read the detailed description
Design: a multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial.
The trial will enroll outpatients of either gender aged 3 to 12 years with clinical manifestations of acute respiratory viral infection (ARVI) within the first 24 hours after the disease onset. Patient enrollment will be conducted in 2 stages during the seasonal incidence of ARVI. First, children aged 6-12 years will be enrolled in the trial. Once the required number of patients is reached, an "unblinded" interim analysis with the primary efficacy endpoint assessment and safety analysis will be performed. Based on the data from the unblinded interim analysis, a decision will be made whether the age range of enrollment can be expanded from 3 to 12 years. Patient enrollment will not be stopped until the results of the "unblinded" interim analysis are available.
After the parent/adopter signs the information sheet and informed consent form for the patient's parents/adopters to participate in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, and concomitant therapy will be recorded. The severity of ARVI symptoms will be assessed using a 4-point scale.
The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be performed prior to therapy to confirm the viral etiology of ARVI.
If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1), they will be randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days.
The trial will utilize an electronic patient diary (EPD) where the patient will make daily records of morning and evening axillary body temperature (measured with a classic mercury-free thermometer) and symptoms of the disease (ARVI Symptom Severity Score). In addition, antipyretic dosing (if applicable) as well as any possible worsening of the patient's condition (if applicable, to assess safety / to record adverse events) will also be recorded in the patient diary. The investigator will instruct the parent/adopter on how to complete the diary. At Visit 1, the parent/adopter together with the physician will record the severity of ARVI symptoms and body temperature in the diary.
The patient will be observed for 14 days (screening, randomization - up to 1 day, treatment - 5 days, follow-up - up to 2 days; deferred "phone visit" - day 14).
During the treatment and follow-up period, patients/physicians will pay 3 visits, and the fourth "phone visit" will be scheduled additionally: 1) physician/patient visits - on days 1, 5 and 7 (Visits 1, 2 and 3) - at the health center or at home; 2) a phone "visit" by the physician (Visit 4) - on day 14.
During Visits 2 and 3, the physician will perform objective examination, record changes in the disease symptoms, concomitant therapy, and monitor the completion of the diary. During Visit 3, compliance will be assessed and laboratory tests will be performed.
A phone "visit" will be performed to interview the parent/adopter about the patient's condition, presence/absence of secondary bacterial/viral complications, and use of antibiotics.
Symptomatic therapy and therapy for concomitant diseases will be permitted during the trial except for the drugs listed under "Prohibited Concomitant Treatment".
- Conditions
- Acute Respiratory Viral Infection
- Being tested
- Raphamin, Placebo
- Keywords
- respiratory viral infection, children, aged 3-12 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaphaminDrug
Also called MMH-407
Tablet for oral use.
PlaceboDrug
Tablet for oral use.
| Study group | Role | What they receive |
|---|---|---|
| Raphamin | Experimental | Per os without food. The tablet should be kept in mouth until completely dissolved.
On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days. Receives: Drug: Raphamin |
| Placebo | Placebo comparator | Placebo using the Raphamin dosage regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of ARVI symptoms (PCR-confirmed)
Time from recording the disease symptoms at Visit 1 until resolution of the disease symptoms.
Resolution of ARVI symptoms will be defined if axillary temperature is ≤37.3°C for 24 hours (without further increase during observation period) + lack/presence of ARVI general symptoms ≤2 points. Based on the patient's diary.
Measured: 14 days
Secondary outcomes (15)
ARVI severity (clinically diagnosed, including PCR-confirmed)
Вased on the area under curve (AUC) results for the total severity score. The total disease severity score will be calculated based on the severity of each of the ARVI symptoms (body temperature, general symptoms, and nasal/throat and chest symptoms in points). To calculate the total score, absolute values of body temperature measured in degrees Celsius will be converted into relative units (or points) based on the following classification: ≤37.3°C=0 points; 37.4-38.0°C=1 point; 38.1-39.0°C=2 points; ≥39.1°C =3 points.
Measured: From day 1 to day 6
Percentage of patients with resolution of ARVI symptoms
Clinically diagnosed, including PCR-confirmed. Based on medical records.
Measured: 14 days
Time to resolution of ARVI symptoms
Clinically diagnosed, including PCR-confirmed. Based on medical records.
Measured: 14 days
Percentage of patients with resolution of ARVI symptoms (PCR-confirmed)
Based on medical records.
Measured: 14 days
Dosing frequency of antipyretics
Based on the patient's diary.
Measured: From day 1 to day 3
Percentage of patients with worsening of the disease
Development of complications requiring antibiotics or hospitalization.
Measured: From day 4 to day 14
Number of Participants With Adverse Events (AEs)
Presence and nature of adverse events during therapy. Based on medical records.
Measured: From day 1 to day 6
Severity of AEs
The intensity (severity) of adverse events. Based on medical records.
Measured: From day 1 to day 6
Causal Relationship of AEs to the Sudy Drug
The causal relationship to the study drug of adverse events. Based on medical records.
Measured: From day 1 to day 6
Outcome of AEs
The outcome of adverse events. Based on medical records.
Measured: From day 1 to day 6
Changes in Vital Signs (Blood Pressure) measured in mm Hg
Blood Pressure measured in mm Hg. Based on medical records.
Measured: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Heart Rate)
Pulse Rate measured in beats per minute. Based on medical records.
Measured: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Breathing Rate)
Respiratory Rate measured in breaths per minute. Based on medical records.
Measured: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Axillary temperature)
Temperature is measured in the armpit using a classic mercury-free thermometer. Based on medical records.
Measured: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Percentage of Patients With Clinically Significant Abnormal Laboratory Tests
Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which are beyond the reference values.
Measured: On Visit 1 (day 1) and Visit 2 (day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start11 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, randomized, parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715891
- Sponsor's protocol ID
- MMH-407-010
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 3-12 Years
- ClinicalTrials.gov ID
- NCT06715891
- Acronym / sponsor ID
- MMH-407-010
- Conditions
- Acute Respiratory Viral Infection
- Keywords
- respiratory viral infection, children, aged 3-12 years
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
Detailed description
Design: a multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial.
The trial will enroll outpatients of either gender aged 3 to 12 years with clinical manifestations of acute respiratory viral infection (ARVI) within the first 24 hours after the disease onset. Patient enrollment will be conducted in 2 stages during the seasonal incidence of ARVI. First, children aged 6-12 years will be enrolled in the trial. Once the required number of patients is reached, an "unblinded" interim analysis with the primary efficacy endpoint assessment and safety analysis will be performed. Based on the data from the unblinded interim analysis, a decision will be made whether the age range of enrollment can be expanded from 3 to 12 years. Patient enrollment will not be stopped until the results of the "unblinded" interim analysis are available.
After the parent/adopter signs the information sheet and informed consent form for the patient's parents/adopters to participate in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, and concomitant therapy will be recorded. The severity of ARVI symptoms will be assessed using a 4-point scale.
The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be performed prior to therapy to confirm the viral etiology of ARVI.
If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1), they will be randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days.
The trial will utilize an electronic patient diary (EPD) where the patient will make daily records of morning and evening axillary body temperature (measured with a classic mercury-free thermometer) and symptoms of the disease (ARVI Symptom Severity Score). In addition, antipyretic dosing (if applicable) as well as any possible worsening of the patient's condition (if applicable, to assess safety / to record adverse events) will also be recorded in the patient diary. The investigator will instruct the parent/adopter on how to complete the diary. At Visit 1, the parent/adopter together with the physician will record the severity of ARVI symptoms and body temperature in the diary.
The patient will be observed for 14 days (screening, randomization - up to 1 day, treatment - 5 days, follow-up - up to 2 days; deferred "phone visit" - day 14).
During the treatment and follow-up period, patients/physicians will pay 3 visits, and the fourth "phone visit" will be scheduled additionally: 1) physician/patient visits - on days 1, 5 and 7 (Visits 1, 2 and 3) - at the health center or at home; 2) a phone "visit" by the physician (Visit 4) - on day 14.
During Visits 2 and 3, the physician will perform objective examination, record changes in the disease symptoms, concomitant therapy, and monitor the completion of the diary. During Visit 3, compliance will be assessed and laboratory tests will be performed.
A phone "visit" will be performed to interview the parent/adopter about the patient's condition, presence/absence of secondary bacterial/viral complications, and use of antibiotics.
Symptomatic therapy and therapy for concomitant diseases will be permitted during the trial except for the drugs listed under "Prohibited Concomitant Treatment".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, randomized, parallel-group
| Arm | Type | Receives |
|---|---|---|
| Raphamin | Experimental | Drug: RaphaminPer os without food. The tablet should be kept in mouth until completely dissolved. On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo using the Raphamin dosage regimen. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of either gender aged 3 to12 years .
- Diagnosis of ARVI based on the medical examination: axillary temperature ≥37.8°C at the time of examination + total severity of general symptom score ≥4 points, nasal/throat/chest symptoms ≥2 points (ARVI Symptom Severity Score).
- 24 hours from the ARVI onset .
- Availability of a patient information sheet and an informed consent form for the patient's parents/adopters for patient participation in the clinical trial signed by one parent/adopter of the patient.
Key exclusion criteria (15 listed)
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring the administration of antibiotics from the first day of disease.
- Suspected early manifestations of diseases that have onset symptoms similar to those of ARVI (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue diseases and other pathologies).
- Patients who require administration of antiviral medications that are prohibited for use in this trial.
- History or prior diagnosis of primary and secondary immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaphaminAlso: MMH-407Tablet for oral use. | Drug | Raphamin |
| PlaceboTablet for oral use. | Drug | Placebo |
Primary outcome
Time to resolution of ARVI symptoms (PCR-confirmed)
Time frame: 14 days
Time from recording the disease symptoms at Visit 1 until resolution of the disease symptoms. Resolution of ARVI symptoms will be defined if axillary temperature is ≤37.3°C for 24 hours (without further increase during observation period) + lack/presence of ARVI general symptoms ≤2 points. Based on the patient's diary.
15 secondary outcomes
ARVI severity (clinically diagnosed, including PCR-confirmed)
Time frame: From day 1 to day 6
Percentage of patients with resolution of ARVI symptoms
Time frame: 14 days
Time to resolution of ARVI symptoms
Time frame: 14 days
Percentage of patients with resolution of ARVI symptoms (PCR-confirmed)
Time frame: 14 days
Dosing frequency of antipyretics
Time frame: From day 1 to day 3
Percentage of patients with worsening of the disease
Time frame: From day 4 to day 14
Number of Participants With Adverse Events (AEs)
Time frame: From day 1 to day 6
Severity of AEs
Time frame: From day 1 to day 6
Causal Relationship of AEs to the Sudy Drug
Time frame: From day 1 to day 6
Outcome of AEs
Time frame: From day 1 to day 6
Changes in Vital Signs (Blood Pressure) measured in mm Hg
Time frame: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Heart Rate)
Time frame: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Breathing Rate)
Time frame: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Axillary temperature)
Time frame: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Percentage of Patients With Clinically Significant Abnormal Laboratory Tests
Time frame: On Visit 1 (day 1) and Visit 2 (day 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Raphamin in people with Acute Respiratory Viral Infection, run by Materia Medica Holding at 35 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikhail Putilovskiy, MD,PhD (+74952761571 ext. 302, PutilovskiyMA@materiamedica.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of ARVI symptoms (PCR-confirmed) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.